Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?

• Status: Terminated
• Trial end date: 2019-08-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Morphine; Ondansetron

Criteria

Inclusion Criteria:

• 3-17 years

• weight
• scheduled for urologic or orthopedic procedure necessitating intrathecal morphine

• ability to use verbal or pictorial pain assessment tools and techniques

• informed consent and (if applicable) assent

Exclusion Criteria:

• Inability to use verbal or pictorial pain scoring scales

• hypersensitivity to selective 5-HT receptor antagonists

• diagnosed congenital long QT syndrome

• severe hepatic impairment

• pregnancy or nursing mothers